EP1952837A1 - Device for siphoning a substance - Google Patents

Abstract

The device (1) has an adapter for securing and coupling a pen ampoule (2) and an ampoule (6) relative to each other for siphoning a substance contained in the pen ampoule into the ampoule. A pusher (4a) and a stopper (3) are acted on the pen ampoule such that the substance contained in the pen ampoule is displaced from the pen ampoule and transferred into the ampoule via the coupling formed by the adapter. The adapter includes male and female luer connectors for coupling connectors or openings of the pen ampoule and the ampoule to be filled. An independent claim is also included for a system including a siphoning device and a storage container.

Description

The present invention relates to a device for transferring a substance, and in particular a drug, such as insulin or hormones, for example, to fill an ampule used in a pump from a purchased ampule or from another reservoir containing the medicament.

Devices for transferring drugs, usually using so-called disposable syringes, have long been known. In essence, the cannula of a disposable syringe is pushed through a piercing membrane of a normal drug container and a drug is drawn from the drug container through the cannula into the disposable syringe.

The same Umfüllvorgang is also the filling of a disposable ampule, which is used in an infusion pump or a Injektionspen based. Such infusion pumps are eg from the EP 0 143 895 known. Injektionspens are eg from the WO 87/02895 known. Disposable ampoules differ from disposable syringes in that the plug is designed not for manual manual feed, but rather for coupling to an electromechanical drive device.

The filling of the disposable ampoules intended for use in infusion pumps takes place in most cases from a rigid storage container, which is provided at the front end with a piercing membrane and compared to the disposable ampoule has a much larger capacity. Typical are about 10 ml for the storage container and 3 ml for the disposable ampoule. However, the process of a sterile and bubble-free transfer is comparatively error-prone and time-consuming for the patient. The transfer from a so-called Penampulle, which is comparable to the filling volume of the disposable ampoule, is considerably simpler Amount of medication includes. The Penampulle is equipped at the front end with a Durchstechmembran and at the rear end with a sliding plug, whereby the drug can be displaced comparable to a syringe by displacement of the plug from the cylindrical ampoule body. The disposable ampoule is equipped at the front end with a piercing membrane or a fluidic connector, for example in the form of a male Luer connector. At the rear end of the drug volume is comparable to a syringe with a sliding plug completed, which is coupled when used in the infusion pump with their drive.

From the DE 299 15 878 U1 a device for transferring medicaments is known with a container whose rear opening is closed by a movable plug connected to a piston rod and whose front-side opening opens into a first cannula, wherein a second cannula is arranged next to the first cannula.

It is an object of the present invention to propose a device for transferring a substance or a medicament, which is easy to operate by a user and which simplifies the transfer of medicaments.

This object is achieved by a device according to claim 1. Advantageous embodiments are defined in the dependent claims.

A device for transferring a substance, such as a drug or medicament, insulin or hormone-containing solution, from a reservoir, such as a pen-ampule into an ampule, which can be inserted into a pump, such as an insulin pump cartridge an adapter or a holding device to align the reservoir and to be filled ampule relative to each other and hold or fix and couple. In this case, the adapter preferably has a guide element or a holder for the reservoir, so for example the pen ampoule, and for the vial to be filled, so that these two containers or ampoules can be aligned relative to each other and preferably fixed in the aligned position. For this purpose, a guide element of the adapter can project, for example, as a part projecting beyond the ampoule or an ampoule end Sheath be formed. It is also possible to design the adapter in such a way that the ampoules are aligned relative to one another and preferably fixed or held in such a way that a guide or holder for aligning the respective container or the respective ampoule is provided only at its inlet or outlet opening. Furthermore, the transfer device has a displaceable or insertable into the storage or dispensing container displacement body or plunger with which, for example, a plug into the reservoir or in the supply vial can be inserted.

The adapter according to the invention thus preferably has holders for the storage container, that is, for example, a pen ampoule, and the container to be filled, for example, a pump ampoule, wherein advantageously the holder is formed so that at least 1/5 of the axial length of the respective container or the respective ampoule can be included or held. Generally, the term "adapter" in the context of the invention, an element to be understood, which aligns the two ampoules or containers relative to each other or positioned or holds.

The adapter may also be designed so that no fluidic coupling of the containers or ampoules is realized by the adapter alone and the containers or ampoules, for example by corresponding guide webs or guide projections relative to each other in a desired arrangement, for example coaxially aligned. The containers or ampoules can then be coupled, for example, by means of a per se known cannula attachable to an ampoule for transferring the substance from one container to another.

In one embodiment, the adapter for the correct orientation of the ampoules may be formed as a longitudinally hinged element, in which the ampoules are inserted so that the openings, for example, facing each other. In this case, the ampoules can already be fluidly coupled or only subsequently coupled, for example, with a coupling piece. Subsequently, the adapter can be folded in order to fix the ampoules in their inserted position and to carry out the fluid transfer, for example with the aid of a plunger.

In order to allow the fluid transfer process to proceed evenly, a spring element can be provided on the adapter, which, for example, by pulling out the plunger is raised or stretched. After the ampoules have been inserted and positioned, the ram locked in, for example, the withdrawn position can be released or released so that the plunger is forced evenly into the ampule by the biased spring force to smoothly transfer the fluid into the ampule to cause filling ampoule.

For uniform transfer of fluid or fluid, the plunger may also be threadedly coupled to the adapter such that the plunger must be threaded into the adapter to effect the fluid transition, thereby preventing jerky or rapid and non-uniform transmission of the fluid becomes.

Optionally, a gas or Luftabscheidemembran be provided in a coupling piece for fluid transmission, to prevent that a contained in the ampoule with the substance to be dispensed air is transferred into the vial to be filled. Air separating membranes or air filters which are gas or air permeable but not fluid permeable are known in the art.

Preferably, the storage containers or ampoules are shipped pre-assembled so that an adapter is already placed on each storage container or each ampoule. For example, a set of, for example, ten delivered reservoirs or ampoules, each with an attached adapter, can be fitted with a single pestle, which can be used multiple times.

According to one embodiment, the adapter has at least one and preferably two latching elements in order to lock the adapter to the ampoule holder by means of a latching element and to latch the adapter by means of a further latching element with the ampoule to be filled, at which corresponding counter-latching elements may be provided at the discharge opening can.

The adapter should be designed for hygienic and regulatory reasons as a disposable part.

Figur 1

die Anordnung der umzufüllenden Ampullen bei Verwendung einer Ausführungsform der Umfüllvorrichtung im Ausgangszustand;

Figur 2

die Ampullenanordnung von Figur 1 im Endzustand;

Figur 3

eine Ausführungsform einer aufklappbaren Umfüllvorrichtung;

Figuren 4 und 5

Ausführungsformen zur Halterung der Ampullen,

Figur 6

eine Detailansicht des hinteren Endes einer Umfüllvorrichtung;

Figuren 7 bis 9

Ausführungsformen des vorderen Endes einer Ampunenumfüllvorrichtung.

The invention will be described below with reference to exemplary embodiments. Show it:

FIG. 1

the arrangement of umzufüllenden ampoules when using an embodiment of the Umfüllvorrichtung in the initial state;

FIG. 2

the ampoule arrangement of FIG. 1 in the final state;

FIG. 3

an embodiment of a hinged transfer device;

FIGS. 4 and 5

Embodiments for holding the ampoules,

FIG. 6

a detail view of the rear end of a transfer device;

FIGS. 7 to 9

Embodiments of the Front End of an Ampunenumfüllvorrichtung.

FIG. 1 and FIG. 2 show the basic arrangement of the ampoules held by a transfer device 1, wherein a pen ampoule 2 is to be transferred to an insulin cartridge or insulin pump cartridge 6, in the initial and final state, ie before the beginning and after completion of the transfer process. The following are based on the FIG. 3 described Umfüllvorrichtung holds the ampoules 2, 6 fixed in the relative position shown, for example, after the empty ampoule 6 was first used with a provided at the inlet and discharge port cannula 8 and the filled ampoule 2 with a septum 9 at the discharge opening. The ampoules 2 and 6 are arranged coaxially with one another in the embodiment shown and are held in the arrangement shown, for example, by holding elements, stops 1d and / or clamps If of the transfer device 1, as described below with reference to FIGS FIGS. 4 and 5 described.

A user operable plunger 4a with handle 4b can be inserted into the transfer device 1 and presses with its front on a displaceable in the ampoule 2 plug 3, so as to empty the ampoule 2 and the substance contained in the ampoule 2 via the fluid connection which has been created by the piercing into the septum 9 cannula 8, to be transferred to the filling ampoule 6, wherein the plug 7 of the ampoule 6 is pushed during the Umfüllvorganges to the rear end of the ampoule 6, as in FIG. 2 shown.

After the refilling process, the ampoules 2 and 6 can be removed from the transfer device 1.

FIG. 3 shows in plan view schematically an unfolded Umfüllvorrichtung 1, in which the ampoules 2 and 6 are inserted after the fluid connection between the ampoules by insertion of the cannula 8 of the ampoule 6 in the septum 9 of the ampoule 2 was prepared. The Umfüllvorrichtung 1 consists of two, for example, semi-cylindrical shells 1a and 1b, which are hingedly connected together by a hinge 1c, in which axial stops 1d and radial clamps 1e, 1f, for example, as ribs for holding the ampoules 2 and 6 in the folded state of Shells 1a, 1b can be integrated, the ampoules 2 and 6 are inserted in the unfolded state in the transfer device 1. For the actual Umfüllvorgang the shells 1a and 1b are folded by a user, the folding operation in an axial plan view in the FIGS. 4 and 5 The collapsed trays 1a and 1b can be held together by a user with one hand, wherein the ampoules 2, 6 are fixed or clamped, while with the second hand the plunger 4a can be inserted into the transfer device 1 for transferring the ampoules.

For visual monitoring of the transfer process, one or both half-shells 1a, 1b of the transfer device 1 may consist entirely or partly of a transparent material. Similarly, cutouts or slots in one or both half-shells 1a, 1b may be provided to allow visual control of the transfer process.

In addition to the arrangement shown, other variants are possible, such as a clamping of the ampoules with three or more clamping ribs 1f, which are then arranged at an angle of, for example, 120 ° to each other. Furthermore, the holding together of the shells 1a, 1b instead of by the hand of the patient, for example, with a snap-or snap closure.

The plunger 4a can also be designed as a spindle with external thread, while the plunger guide, which is for example part of the transfer device 1 or a half-shell 1a, 1b, contains an internal thread. In this case, the decanting can be done very sensitively by a rotational movement of the plunger 4a. Another alternative consists in a spring drive, wherein, for example, the plunger 4a is inserted or screwed by a tensioned spring in the transfer device 1.

Instead of a simple cannula 8 for coupling the ampoules 2, 6, an adapter or coupling part with integrated Luflabscheider can be used. In this way, the existing in the Penampulle 2 air during the transfer process is automatically removed by a corresponding mechanical arrangement, it is also possible to couple a filling aid to the pump and to use the motor movement of the pump drive or the motorized retraction of the pump threaded rod for transfer.

FIG. 6 shows a further embodiment of a transfer device 1, which has an ampoule holder 1 g, in which the ampoule 2 is inserted with the substance to be dispensed.

This ampoule 2 in turn has a displaceable plug 3 in order to displace the substance contained in the ampoule 2. Another component is a plunger 4a, which is coupled to the ampoule holder 1g and can be pushed onto the ampoule holder 1g or inserted into it, that a rod attached to the plunger 4a acting on the plug 3 rod the plug 3 during insertion of the plunger 4a einschiebt into the ampoule holder 1 in the ampoule 2 and so displaces the substance from the ampoule 2 and emits. As the third element, an adapter 5 is provided, on which an adapter attachment 5a is placed. The adapter 5 couples the discharge opening or the outlet of the ampoule 2 to the opening of the ampoule 6 to be filled, so that during the displacement of the plug 3 of the ampoule 2 with the substance to be dispensed, this substance passes through the adapter 5 into the ampoule 6 to be filled can.

In principle, it is also possible to integrate the adapter 5 in the ampoule holder 1, although the use of a separate adapter 5 is preferred, for example, provided on the adapter 5 in the to be filled ampoule 6 and / or in the emptying ampoule. 2 einzustchende needle 8 for reasons of hygiene should be used only once.

The FIGS. 7 to 9 show various embodiments of the coupling of the ampoule 6 to be filled with the transfer device 1 or the ampoule 2 containing the substance to be filled.

FIG. 7 shows an embodiment of a transfer device 1, wherein the to be filled, for example, plastic or plastic existing ampoule 6 is fluidly coupled to the pen ampoule 2 by means of a cannula 8, which is connected to the filling ampoule 6 and through a septum 9 of the pen 2 is inserted, so as to provide a fluid connection between the interior of the two ampoules.

FIG. 8 Figure 8 shows another embodiment of a coupling of the ampoules 2 and 6, the ampoule 6 to be filled having a male luer lock 10a which is connected to a female luer lock 10b of the pen ampoule 2 for fluid communication between the ampoules 2 and 6 produce.

FIG. 9 shows a further embodiment of a transfer device 1, in which on an Male Luer connector 10a of the ampule to be filled 6, an adapter 5 is placed, which consists of a female Luer connector 10b, in which a cannula 8 is inserted, with which a septum 9 of the pen ampoule 2 can be punctured.

Claims (12)

Transfer device for transferring a substance, in particular a drug, from a storage container (2) into an ampoule (6), which can be inserted into a metered substance delivery device, with an adapter (1, 5), relative to the reservoir and the ampoule holding and coupling to each other in order to be able to transfer a substance contained in the storage container (2) into the ampoule (6) and with a displacement element (4a, 3) which can act on the storage container (2) in the storage container (2) to displace substance contained in the reservoir (2) and to the ampoule (6) via the coupling realized by means of the adapter (5). Transfer device according to claim 1, wherein the displacement element is a plunger (4a) or an insertable into the transfer device, which can act on the reservoir (2) or a plug (3) of the reservoir (2) to the reservoir (2) deform and / or to move the plug (3) within the reservoir (2). Transfer device according to one of the preceding claims, wherein the adapter (5) has a male luer connection (10a), a female luer connection (10b) and / or a cannula (8) around the connections or openings of the storage container (10). 2) and to couple the ampoule (6) to be filled. Transfer device according to one of the preceding claims, wherein the adapter (5) at least one guide element (1d, 1f) to the reservoir (2) and / or to be filled ampoule (6) relative to the adapter (5) and / or relative to each other to align in a defined positional relationship. Transfer device according to the preceding claim, wherein the guide element has an ampoule holder or a latching element. Transfer device according to one of the preceding claims, wherein the displacement element or the plunger (4a) is guided on or in the adapter (1, 5). Transfer device according to one of the preceding claims with at least one or two preferably semi-cylindrical shells (1a, 1b), in which the storage container (2) and / or the ampoule (6) can be inserted. Transfer device according to one of the preceding claims, wherein the transfer device has a hinged element (1a, 1b) into which the storage container (2) and / or the ampoule (6) can be inserted in the opened state and which in the collapsed state the storage container (2 ) and / or the ampoule (6) can fix. Transfer device according to one of the preceding claims, wherein the transfer device and / or the adapter (5) comprises a transparent material or viewing slits to the filling state of the reservoir (2) and / or the ampoule (6) to recognize. Transfer device according to one of the preceding claims, wherein the plunger (4a) is a spindle or threaded or is driven by a spring drive or is coupled to a motor of a pump, in particular a device for metered administration of a substance. Transfer device according to one of the preceding claims, wherein the adapter (5) or an element in the region of the coupling of the storage container (2) with the ampoule (6) is made of an air-permeable material in order to deposit gas contained in the substance. System with a transfer device according to one of the preceding claims and a storage container (2) and / or an ampoule (6).

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